Scientific Opinion on the safety and efficacy of beta‐carotene as a feed additive for all animal species and categories

The use of beta‐carotene is safe for the target animals. Setting a maximum content in feed legislation is not considered necessary. However, this conclusion assumes that triphenylphosphine oxide does not exceed 100 mg/kg additive. In all food‐producing animals (except veal calves) and laboratory rodents, beta‐carotene is almost fully metabolised. In contrast, humans, non‐human primates and ferrets absorb relatively high quantities of beta‐carotene unchanged. Investigations with ferrets and hamsters as well as intervention studies in humans may indicate a certain dose‐dependent potential of beta‐carotene to promote lung carcinoma, particularly in smokers. A systematic literature review and meta‐analysis of nine randomised controlled trials demonstrated an increased risk of lung and stomach cancers in smokers and asbestos workers at dose levels ≥ 20 mg/day. However, increased risk of lung cancer at such doses could be observed only if plasma levels of beta‐carotene exceeded 3 µmol/L. The FEEDAP Panel considers it prudent, in the absence of an acceptable daily intake, that supplemental beta‐carotene in animal feed should not significantly add to consumer exposure from other sources. The use of supplemental beta‐carotene in feeds of food‐producing animals, except veal calves, would not result in a significant additional exposure of consumers to beta‐carotene; however, consumption of liver from veal calves could lead to additional exposure. Beta‐carotene is not an irritant to eyes or skin and is not a skin sensitiser. Respiratory exposure from handling beta‐carotene‐containing additives is considered potentially hazardous. Taking the widespread occurrence of beta‐carotene in nature and its oxidative susceptibility into account, the FEEDAP Panel considered it unlikely that the use of beta‐carotene in animal nutrition at the recommended feed concentrations would pose a risk to the environment. Beta‐carotene is utilised for the synthesis of retinol in almost all animal species except the cat. Effects on reproduction and immunity were not sufficiently demonstrated.